Continuous delivery methods for treating hepatitis virus infection

a technology for hepatitis virus infection and continuous delivery, which is applied in the direction of peptide/protein ingredients, other medical devices, organic active ingredients, etc., can solve the problems of non-responders or relapsers, 40% to 50% of patients failing therapy, and patients currently have no effective therapeutic alternativ

Inactive Publication Date: 2009-09-10
THREE RIVERS PHARMA LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides methods for treating hepatitis C virus (HCV) infections by administering an interferon receptor agonist to a patient in a continuous or continuous manner for at least about 6, 12, or 24 weeks, or at least about 48 weeks, or at least about 60 weeks. The methods involve achieving and maintaining a sustained serum concentration of the interferon receptor agonist at a substantially steady state for a treatment period of at least about 6 weeks, or at least about 12 weeks, or at least about (24) weeks, or at least about (48) weeks, or at least about (60) weeks. The methods can be effective in treating HCV infections, reducing viral load, and achieving a sustained viral response. The interferon receptor agonist can be IFN-α, IFN-γ, or IFN-β. The method can use an implantable infusion pump to administer the interferon receptor agonist."

Problems solved by technology

Nevertheless, even with combination therapy using PEGylated IFN-α plus ribavirin, 40% to 50% of patients fail therapy, i.e., are nonresponders or relapsers.
These patients currently have no effective therapeutic alternative.
In particular, patients who have advanced fibrosis or cirrhosis on liver biopsy are at significant risk of developing complications of advanced liver disease, including ascites, jaundice, variceal bleeding, encephalopathy, and progressive liver failure, as well as a markedly increased risk of hepatocellular carcinoma.
Since the risk of HCV-related chronic liver disease is related to the duration of infection, with the risk of cirrhosis progressively increasing for persons infected for longer than 20 years, this will result in a substantial increase in cirrhosis-related morbidity and mortality among patients infected between the years of 1965-1985.

Method used

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  • Continuous delivery methods for treating hepatitis virus infection
  • Continuous delivery methods for treating hepatitis virus infection
  • Continuous delivery methods for treating hepatitis virus infection

Examples

Experimental program
Comparison scheme
Effect test

example 1

Study Evaluating the Safety and Efficacy of Infergen Administration by Continuous Delivery Using a Subcutaneous Pump in Combination with Oral Ribavirin in Patients Infected with Hepatitis C Virus who are Treatment Naïve or Peginterferon-Alfa Plus Ribavirin Non-Responders

Study Drugs / Device

[0443]Infergen (interferon alfacon-1 [also known as consensus interferon or CIFN]); ribavirin 200 mg capsules; and Medtronic, Inc. MiniMed Pump—Model 508.

Objectives

[0444]Primary Objective: Evaluate the safety and tolerability of Infergen administered by continuous infusion at 2 doses (12 μg / day or 18 μg / day) using a subcutaneous pump in combination with daily oral ribavirin in HCV-infected patients who have failed pegylated interferon therapy, or who are therapy naïve.

[0445]Secondary Objectives Assess the early viral response at (Weeks 1, 4, 12, and 24); assess the sustained viral response (Week 72); and assess the pharmacokinetic profile of Infergen delivered by continuous infusion.

Study Design

[044...

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Abstract

The present invention provides methods of treating hepatitis virus infection. The methods generally involve administering an IFN-x by continuous delivery. Continuous delivery of IFN-x provides for a serum profile of IFN-x such that a sustained viral response is achieved.

Description

FIELD OF THE INVENTION[0001]This invention is in the field of treatments for viral infections, in particular hepatitis virus.BACKGROUND OF THE INVENTION[0002]Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States. Although the numbers of new infections have declined, the burden of chronic infection is substantial, with Centers for Disease Control estimates of 3.9 million (1.8%) infected persons in the United States. Chronic liver disease is the tenth leading cause of death among adults in the United States, and accounts for approximately 25,000 deaths annually, or approximately 1% of all deaths. Studies indicate that 40% of chronic liver disease is HCV-related, resulting in an estimated 8,000-10,000 deaths each year. HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults.[0003]Antiviral therapy of chronic hepatitis C has evolved rapidly over the last decade, with significant impro...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61P31/12A61K38/21A61M37/00A61KA61K31/7056A61K45/00A61K45/06
CPCA61K31/7056A61M39/24A61K45/06A61K38/212A61P31/12
InventorBLATT, LAWRENCE M.MURPHY, BRIAN
OwnerTHREE RIVERS PHARMA LLC